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Spinal Morphine for Patients With Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intrathecal Morphine
No Intrathecal Morphine
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Spinal morphine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults, aged 18-85
  2. ASA physical status I-III
  3. Suspected of having Obstructive Sleep Apnea(OSA) or previously diagnosed with OSA
  4. Scheduled to undergo elective primary Total Hip or Knee Arthroplasty

Exclusion Criteria:

  1. Chronic obstructive pulmonary disease
  2. Asthma
  3. History of congestive heart failure
  4. Valvular disease
  5. Dilated cardiomyopathy
  6. Implanted pacemaker or defibrillator
  7. Diagnosed OSA who are undergoing continuous positive airway pressure (CPAP) treatment
  8. Contraindications to spinal anesthesia
  9. Contraindications to a component of multi-modal analgesia
  10. Local anesthetic allergy
  11. Anticipated surgical duration > 2.5hrs
  12. Opioid tolerance (>250mg/24hr oral morphine equivalent pre-operatively)
  13. Pregnancy
  14. History of significant cognitive or psychiatric condition that may affect patient assessment, or
  15. Inability to provide informed consent.
  16. Participation in other clinical studies

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intrathecal morphine

No Intrathecal morphine

Arm Description

100μg of morphine will be added to the intrathecal mixture.

Morphine will not be added to the intrathecal mixture.

Outcomes

Primary Outcome Measures

Average Oxygen Desaturation Index (ODI) for the first 72 hours postoperatively.
Oxygen Desaturation Index (ODI) is defined as the average number of episodes of desaturation ≥ 4% lasting at least 10 seconds, per hour of sleep. ODI will be measured with a nocturnal pulse oximeter.

Secondary Outcome Measures

Full Information

First Posted
February 11, 2013
Last Updated
March 15, 2019
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01790971
Brief Title
Spinal Morphine for Patients With Obstructive Sleep Apnea
Official Title
Low Dose Spinal Morphine for Patients With Obstructive Sleep Apnea (OSA) Undergoing Total Hip Arthroplasty (THA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Suspended
Why Stopped
competing studies
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with Obstructive Sleep Apnea (OSA) appear to be especially vulnerable to medications that suppress pharyngeal muscle activity such as general anesthetics and opioids. Opioids can depress the ventilator response to airway obstruction and inhibit the awakening response to hypoxia and hypercarbia, resulting in central respiratory depression. OSA is therefore an important risk factor for serious postoperative complications, including perioperative death. While OSA is increasingly recognized as a serious perioperative concern, current clinical practices are highly inconsistent with regard to the management of surgical patients with OSA. Additionally, the relative safety of intrathecal opioids in this patient population remains unknown.
Detailed Description
Total hip and knee arthroplasty (THA and TKA) are among the most common orthopedic procedures performed worldwide1. They have been shown to reduce chronic pain, increase the ability to function independently, and improve quality of life2,3. With an aging and increasingly obese North American population, the uses of THA and TKA are increasing 4. One of the main challenges associated with THA as well as TKA continues to be the perioperative management of patients who are elderly or obese, and their associated co-morbidities. Both THA and TKA are commonly performed under neuraxial anesthesia. Neuraxial anesthesia has been reported to provide multiple benefits when compared to general anesthesia and/or systemic analgesia including superior post-operative analgesia5, reduced opioid consumption6, improved rehabilitation7, and reduced morbidity and mortality8-12. The addition of opioids to the neuraxial local anesthetic solution has been common practice since 1979, when morphine was first shown to provide effective and prolonged analgesia after intrathecal administration13. For both THA and TKA surgeries, intrathecal morphine provides effective analgesia14-16 allowing for a reduction of the dose of intrathecal local anesthetic (thus minimizing side effects)17, and has a marked postoperative opioid-sparing effect14-16. However, these benefits of intrathecal morphine must be weighed against its risks of pruritis, nausea/vomiting, urinary retention, and, of most concern, respiratory depression18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, Spinal morphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrathecal morphine
Arm Type
Active Comparator
Arm Description
100μg of morphine will be added to the intrathecal mixture.
Arm Title
No Intrathecal morphine
Arm Type
Active Comparator
Arm Description
Morphine will not be added to the intrathecal mixture.
Intervention Type
Drug
Intervention Name(s)
Intrathecal Morphine
Other Intervention Name(s)
Kadian
Intervention Description
Depending on the randomization schedule, 100μg of morphine will or will not be added to the intrathecal mixture.
Intervention Type
Drug
Intervention Name(s)
No Intrathecal Morphine
Other Intervention Name(s)
Kadian
Intervention Description
Depending on the randomization schedule, 100μg of morphine will or will not be added to the intrathecal mixture.
Primary Outcome Measure Information:
Title
Average Oxygen Desaturation Index (ODI) for the first 72 hours postoperatively.
Description
Oxygen Desaturation Index (ODI) is defined as the average number of episodes of desaturation ≥ 4% lasting at least 10 seconds, per hour of sleep. ODI will be measured with a nocturnal pulse oximeter.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults, aged 18-85 ASA physical status I-III Suspected of having Obstructive Sleep Apnea(OSA) or previously diagnosed with OSA Scheduled to undergo elective primary Total Hip or Knee Arthroplasty Exclusion Criteria: Chronic obstructive pulmonary disease Asthma History of congestive heart failure Valvular disease Dilated cardiomyopathy Implanted pacemaker or defibrillator Diagnosed OSA who are undergoing continuous positive airway pressure (CPAP) treatment Contraindications to spinal anesthesia Contraindications to a component of multi-modal analgesia Local anesthetic allergy Anticipated surgical duration > 2.5hrs Opioid tolerance (>250mg/24hr oral morphine equivalent pre-operatively) Pregnancy History of significant cognitive or psychiatric condition that may affect patient assessment, or Inability to provide informed consent. Participation in other clinical studies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Brull, MD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17717242
Citation
Liu SS, Wu CL. The effect of analgesic technique on postoperative patient-reported outcomes including analgesia: a systematic review. Anesth Analg. 2007 Sep;105(3):789-808. doi: 10.1213/01.ane.0000278089.16848.1e.
Results Reference
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Spinal Morphine for Patients With Obstructive Sleep Apnea

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